N/A
N=245
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Breast Biopsy
Bottom Line
View on ClinicalTrials.gov: NCT04398537 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. — 46; 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5mm retraction of clip deployment apparatus. (Device); No retraction of clip deployment apparatus. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. |
46; 44 | — |
| PRIMARY Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. |
46; 44 | — |
| PRIMARY Average Distance of Clip Migration for the Arm That Received 5mm Retraction. |
12.1 | — |
| PRIMARY Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction. |
9.8 | — |
Summary
This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.
Eligibility Criteria
Inclusion Criteria
- Females 18-99 of age with recommendation for stereotactic biopsy.
Exclusion Criteria
- Non-female patients
- Patients < 18 years old
- Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT04398537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.